Randomised, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Tolerability of EPA-FFA Gastro-resistant Capsules, in Patients With Familial Adenomatous Polyposis (FAP)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period
研究概览
简要总结
2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.
详细描述
The purpose of this Phase III study is to determine whether Eicosapentaenoic acid-free fatty acid is a safe and well tolerated treatment in reducing the number of polypectomies FAP patients with an APC gene mutation have over a 2 year treatment period and to assess the effect that this has on clinical disease progression. Planned Sample Size This study will enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.
Secondary objectives is to evaluate the clinical disease progression and the long-term safety and tolerability of EPA-FFA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with ileo-rectal anastomosis who have ≥ 20 polyps which are of >5mm that are not amendable to removal in the rectum.
- •Subjects unwilling to have regular sigmoidoscopy examination.
- •Subjects who are due to undergo gastro-intestinal surgery related to FAP.
- •History of invasive carcinoma in the past 3 years.
- •History of pelvic radiation.
- •Known allergic reaction or intolerant to fish or fish oils.
- •Known allergic reaction to excipients of IMP and placebo.
- •Subjects who are pregnant or breast-feeding at screening.
- •Subjects taking aspirin, other than a low (75mg-100mg) cardioprotective dose on a regular basis, or other nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular basis. Regular use of other NSAIDS is defined in this protocol as use greater than 14-day treatment period, and one treatment per six months for the duration of the study.
- •Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose aspirin).
- •Subjects taking NSAID, 5-aminosalicylic acid (5-ASA or mesalamine).
- •Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Subjects previously taking fish oil must have a washout period of 2 months prior to study enrolment.
- •Subjects who are taking warfarin or other anticoagulants.
- •Experimental agents must have been discontinued at least 8 weeks prior to screening or for a period equivalent to 5 half-lives of the agent (whichever is longer).
- •Subjects suffering from known disorders of clotting and blood coagulation.
- •Subjects who have significant abnormalities on their screening blood tests.
- •Subjects with gastrointestinal malabsorptive disease.
- •Subjects with uncontrolled hypercholesterolaemia.
- •Subjects who are deemed mentally incompetent or have a history of anorexia nervosa or bulimia.
- •Subjects who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile, must use effective contraception (either combined oestrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects' usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP.
- •Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the "postmenopausal range". Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
研究组 & 干预措施
Treatment Group A
Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg
干预措施: Eicosapentaenoic acid free fatty acid (EPA-FFA) (Drug)
Treatment Group B
Placebo 500mg
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period
时间窗: 24 months
Proctectomy is indicated when polyp burden is frequently high in the remaining rectum, if large highly dysplastic polyps occur, or if frank malignancy develops. Proctocolectomy also significantly reduces the cancer risk with the removal of the colon and rectum.
次要结局
- Change in Polyp number at 24 months assessed by blinded review of video records(24 months)
- Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months(24 months)